Okay, I think we'll go ahead and get started. So, my name is Liisa Bayko. I'm a Biotech Analyst at Evercore ISI, covering SMID Cap, and very pleased to be joined by Bill Sibold, who's the new CEO of Madrigal. And I've known Madrigal since really it came out as a company, actually, back in the day. So I remember traveling around with Paul and Becky, and then I, after some interesting dialogue, realized they were actually married. I didn't really know that. So,
It's not where I thought this would start, but-
So I think the company has really kinda grown up since then and evolved and produced some really phenomenal phase 3 data last year, which we did a ton of work on, and I was really excited to see that data. Then I think it's been great to have you on board, Bill, just to really take this company next level, really with your commercial expertise. So I guess let's start off by really, what attracted you to Madrigal? Like, why did you come to Madrigal? You were obviously really successful with Dupixent and your career at Sanofi. So give us a little inside glimpse into your thinking of joining Madrigal.
Well, first of all, thank you for having me. Thank you for having us. It's been a great meeting. You know, look, the bar was high to leave. It was a great role that I was in, so it was gonna take a very special opportunity. And, you know, some of the learnings in the industry over the years is that really success in the industry is built around great assets, and there aren't so many great assets in pharma. You know, there's a lot of good, but great is hard to come by, and every company is striving to have them. And Madrigal has a great asset. I mean, just so much credit to Becky for staying on this journey for so long and seeing the potential.
You know, now, as you know, this has been the graveyard of drug development, and so many before have faded away, that resmetirom is really in the lead position. And for me, in order to leave what I was doing, there had to be a belief that there was a potential to not only build a brand, but to build a company. And because it is a brand which I think can be a significant brand, and you can be leaders with it in NASH, and then extend that leadership in the future, you can be the one in a thousand that makes it.
for me to have that opportunity to build something, which can be a sustainable, you know, valued company, that was what was really attractive, to take all the learnings of the past, you know, 12 years that I was at Sanofi, and then the, you know, other, you know, 28 years in the industry, to have this opportunity present itself.
Great. Well, you've joined the company before approval, but of course, you have to do all your pre-launch, you know, activities now. As you look at the data package you have and headed into this, you know, you're in the middle of the regulatory period with FDA, you know, how are you feeling about approval on March 14th? You know, how are the discussions with FDA going, as much as you can tell us? I know you can't say everything. And any key risks that stand out to you?
A lot of questions in there. Look, I think that, what we're planning on is we're planning for success on March 14th, right? So all of the commercial build, all of the launch preparation is with that date in mind. And, you know, so that's, that's how we've chosen to approach it. You know, clearly, nothing I can say about the regulatory review. If there's anything that's material or important, that's something that we'd communicate to everybody. But, you know, I think the fundamentals are just so positive towards it. I mean, the data package is strong. We hit on both endpoints. I think fibrosis is something that's really important for this population. The unmet need is... Yeah, you can't dispute that, and the FDA knows that as well.
I mean, the FDA, at the end of the day, they want to find solutions for high unmet need diseases. NASH has been, as I mentioned, you know, the graveyard of drug development, and there has been a strong desire to find something, but it has to meet the criteria of being effective and safe. And I think with the profile that we have, you know, we meet that criteria. So, you know, we are and have been collaborating with the FDA for a long time on this.
I think people saw it as a bit of a win-
Mm-hmm
... that there was no Ad Com that was gonna be, you know, required. That and the fact that, of course, it was gonna be a Priority Review.
Mm-hmm.
So those two things. When are we in the clear? Like, if you backtrack, we did a little bit of this last night at our wonderful and very long dinner. When do you feel like you're kind of in the clear that, "You know what? We're probably not gonna have an Ad Com at this point"?
Yeah, you know, look, I'm a little bit of a traditionalist, where once we get approved, we're in the clear on everything. But you know, there is with the FDA, they have a requirement that they give you 55 business days warning of an Ad Com, right? So you just start doing the math of where we are. We're about, you know, 73 business days from approval. So-
About 73.
But, you know-
And a half
Like, I haven't done the math today to look at that. But I mean, look, you know, I think with an Ad Com, it's not a given that every new therapy in a new indication is going to have one. So of the 11 product approvals that I've been a part of over the last 11 years, and it's actually more like 15 launches because, you know, Dupixent, 5 indications, I only had one Ad Com despite 5 or 6 of them being in completely new areas, and the first drug in that area. So it's not a given that you have an Ad Com. So, you know, we'll wait and see. The FDA is the decision maker on that. They'll ultimately make that decision.
But, you know, as I said, we'll have plenty of advance warning, and certainly we'll let people know if, if anything changes. It's obviously encouraging when the communication, when we got the Priority Review, was that no Ad Com at this point.
You've been at the company about two months now, is that right?
Just over. Yep. It's about nine to 10 weeks.
Okay.
Yeah.
Do you feel like you joined late, like, do you have a lot of catching up to do to kind of be able to launch on March 14th? I think you said that you were planning to launch the product on that, around that time.
Yeah.
you know, or do you feel like that's an adequate amount of time?
Yeah. So, you know, first of all, look, approval March 14th is what we're planning on. Practically speaking, by the time, you know, product's out and available, you have to give it a couple of weeks just for practical matters, like you've got to print the boxes, the PI, that's final. And by the time you do that, get product into the channel, et cetera, you know, that's, you know, typically a couple of weeks. But we'll be ready to go, and activities will start on, you know, day one. Look, you never have enough time, and you never have too much time for a launch. You know, there's always more that you can do. Having certainty of a date in your mind, it forces you to be ready for that.
Now, I think that the team had done, you know, a great job in getting us to September 11th when I joined, and now it's really the hard yards, if you will, where it is focusing in on the things that really matter and executing. Up until that point, you know, there's probably 1,000 different things you have to do in order to get ready for a launch, and it's in the final months that you have to make the fine detailed decisions about, you know, exactly what are you gonna execute, how you're gonna execute it. So that's what we've been going through since I joined in September. And we've scaled up, right? We have our medical teams have all been deployed. We have the kinda leadership of the commercial organization, including the sales organization.
And as we turn the calendar, you'll be bringing ultimately the field force on board, and the field force will be, you know, ready to go for March 14th. So, you know, look, you always would like to have more time, but by having, you know, kind of a deadline that you're working towards as well, it forces you to really focus on the things that matter the most, and, you know, that's what we're doing. And, you know, we recently brought in a new chief commercial officer, Carole Huntsman, who's somebody who I had worked with formerly at Sanofi Genzyme. She had left there at the beginning of the year and was, you know, fortunate enough to have her join here.
And, you know, it's somebody who knows what it takes to build a big asset. And launch is interesting, but peak and building a market is a lot more interesting. So as we're hiring people on board, it's not for launch, it's more for peak. Now, the two are, you know, closely related. How you launch and how you create the wiring, if you will, the foundation, will help you accelerate your time to peak, because there will be a defined path for patients to find their way into treating physician, getting product, securing reimbursement, and having a, you know, great experience. So we're spending that time, and really, as we think of 2024, wiring the system, building it, so that we can continue to put more and more patients through in time. And, you know, I think that's a different mindset.
I think a lot of small companies, in particular, the mindset is launch, approval is the destination. For me, approval is really the start of building a great asset and a great company.
You talked a lot about last night, about how important not just the internal hires are that are internal facing, but really those external, external facing people, right? The sales reps-
Mm
... the managers of the sales force. What kind of people are you looking to hire? And I know you didn't want to say too much about the number, but how many people are you gonna target, I guess, at least-
Yeah
... how are you thinking about?
So, I mean, look, just to maybe it helps just to kind of frame out a little bit, kind of who the patient is, who the target is, et cetera. So we're looking at patients that have NASH with significant fibrosis, F2, F3, like, and those patients that are treated by hepatologists and gastroenterologists. So, you know, we wanna have a very targeted launch, not only in the patient that we're looking for, but also the physician that we're gonna call on. When you look, there's about—if you put every kind of gastroenterologist and hepatologist in a bucket, that's about, you know, 15,000, 13,000-15,000, depending on how you do the count. It's a subset of that that really drives the business. So you-
Sorry, is it more hepatology or?
Well, there's just not so many hepatologists-
Okay, okay
... pure defined hepatologists.
How many of those are?
But they have... That is more in the hundreds.
Okay.
Right?
I see.
It's not, it's like if-
Okay
... the really, really, really focused experts. So it's usually, in any launch I've been associated with, it's kind of that, you know, somewhere between, you know, 6,000-8,000 targets are really where you focus a specialty launch. Now, that doesn't mean you don't call on others, but the ones that you're gonna call on more frequently, the ones that are gonna drive a lot of the business, tend to be that, that smaller subset.... So, you know, so we know the patient, we know the physicians. We're, you know, as you, between now and launch, you really begin to get much more specific in each practice. What does it look like? What's the opportunity there? So that you're, then can target the most appropriately, knowing that even when you launch, you're gonna learn things.
Someone who you thought was going to, perhaps be a big treater isn't, or somebody who wasn't, is, so you adjust accordingly. So that's what we'll continue to do to refine, refine, refine, refine. And we think that, you know, specialty sales forces are in that kind of a 150-250 range. We haven't said exactly what our numbers are. I usually don't like saying what our numbers are just from, for competitive reasons. But, you know, we believe that this is a, opportunity that is possible with a very targeted effort, like what we're proposing.
What kind of a person are you looking for?
Right. So, you know, I'm a big believer in experts, you know, people that really understand that customer. So people that have a hepatology background, people that have a gastroenterology background. And that's really important because, what you want is somebody who's familiar with the practices that they're calling on. It really helps, them having access to the actual facility-
Right
... and just that familiarity and trust. So, you know, we're looking for people that have that. But it's not just people that have the expertise. We're not looking for, as I say, mercenaries, that are just out there for the next launch to try to go and have, you know, a few good quarters and then move on to the next launch. We're looking for people that are committed to the space, that wanna work with the community, that wanna partner with the community. It's not a transaction, but very much, you know, we wanna get on the same side of the table and think about how do we help with NASH patients, not only now, but in the future. And so, you know, when we're interviewing, we're testing as much for that fit, as we are for what are the capabilities that they bring.
You're starting to recruit everybody now, and-
Yeah
... you'll start bringing them on board in early 2024.
Yeah, that's essentially the plan.
Okay. You've also been doing quite a bit of market research and market analysis, and when you and I talked at the liver meeting, we talked about some numbers which I've actually, like, I'm really thinking about, like, I'm sort of tweaking my model and really thinking about some of the things you said. So maybe you could share those with people here.
Sure. Okay. So, look, from a population perspective, so there's about 1.5 million diagnosed NASH patients in the U.S., and about 35%-40% are F2, F3. And as I said, that's the population that we're looking at as the most in-need patient. Now, the final piece to that, and we'll provide more details as we get a little bit closer to launch, it's how many of that 35%-40% are in the specialists that we're calling on? So you do that math, and you see it's a sizable opportunity. Now, let me also back up and say: How are we approaching this? This is a specialty launch. And, we've had questions around pricing.
Now, we aren't gonna disclose price until we have approval and launch the product, but, you know, I believe that you price for the value that the product brings. You know, a couple of, you know, just, data points, with that, you know, we have, as a team, I think, done just a really outstanding job with health economics work. You know, I would say that the team, it's like best in class.
Yeah.
So, you know, I think really well done. And also the development program has set really a high bar, I think, for anyone else who's going to develop a NASH product. You know, Becky and team, I have to say, they approach this in such a thorough way that they probably ask questions that not every company would ask, but, you know, in the interest of really pushing the science, they asked it. So we have a great data set, and that shows the value of the product. And if you even look at the ICER analysis that was done, you know, cost effectiveness was in the range of $39,000-$50,000 per year, and it was kind of at a neutral at around $76,000.
So, you know, look, we're not gonna talk about what price is today, or we're not gonna talk about what the price is until, pardon me, until we get to approval. But, you know, as I said, it's a specialty launch. I believe in pricing for the value, and we will provide more details in the future.
ICER set the value. I think they gave a range of $high 30s-$50-.
Yeah
... $1,000 per patient per year. How much is ICER kind of like valued, respected by payers?
Well, look, I think any conversation on any product today is a challenging one with payers, right? I don't think that there's too many products, you know, welcome with open arms to say, you know, "Thank goodness, you're finally here." So I think that, you know, regardless, you're gonna have challenging payer discussions, you know, whether it's a topical therapy or a biologic, or in this case, you know, a liver-directed, safe, well-tolerated oral. And, you know, we expect that that's just part of the way we're gonna, the way you do business here. You know, you have these conversations. We've spoken to a lot of the payers already to educate on the disease, educate to the extent that we can on the product, et cetera.
You know, I think that there's been a pretty steep learning curve of understanding just what kind of problem you're trying to resolve. Remember, these payers own these patients, and these are not inexpensive patients. You know, we often talk in terms of you're trying to avoid liver transplant, right? That's... you're trying to avoid HCC. You're trying to, you know, avoid cardiovascular events.... but if you go before that even, and the cost of patients that become cirrhotic and decompensated, that becomes a really expensive patient. It's like 6x from going from well compensated to a decompensated patient with cirrhosis. All of the payers have access to that and know what it costs. Again, it doesn't mean that you have easy conversations, but we feel like there is enough data to sit down and have a really constructive conversation about it.
Okay, good. You've used this phrase, liver-directed quite a bit.
Yes.
Seems like you're positioning the drug that way, I think, to maybe distinguish a little from not liver-directed therapies out there that are causing a lot of chaos, and bringing a lot of benefit, actually, too. I think that's. I noted that you've been talking about liver-directed, and I heard actually several KOLs talking about wanting liver-directed therapies very specifically.
Mm.
So that kind of brings me to the topic I wanted to address, which is the GLP-1 category. And I think for, you know, for a lot of investors, you know, they look at NASH or MASH, sorry, as sort of downstream of obesity, right? Which, in fact, it is. And so then kind of to solve for that, you know, you can use GLP-1, other obesity agents, which, you know, there's plenty of those coming forward in development. So how are you thinking about the impact of this category of medicines on the MASH market?
Yeah. Well, look, you know, as we said, it's NASH with significant fibrosis, F2, F3. So you've already... These patients are already on a path that isn't a good one, where they've accumulated fibrosis, so scarring of the liver, which then leads to becoming cirrhotic and then decompensated and, you know, everything that's downstream from there. So those are in-need patients that I don't think it's practical to say if you're talking about a GLP-1 in clinical trials, a 20-week dose titration. What we've heard from treating physicians, sometimes it's longer than that, to then get to a therapeutic effect, to then start to have an impact, if they even have an impact on fibrosis somewhere down the road.
When you're in this in-need stage, F2, F3, that's where you want to get straight to the fibrosis. You want something that is liver-directed, you know? So that's where we feel that that population is going to exist with or without the GLP-1s. You know, not everyone's gonna be on a GLP-1. If you were to say, snap your fingers, and every one obese, 110 million people in the U.S. are on a GLP-1. First of all, that's just not, I don't think, possible. Secondly, not everyone's going to tolerate and stay on it. I'm not sure what the persistency at one year is, but I've heard that the numbers are not so great because they aren't the most easily tolerated products, and they've yet to show an impact on fibrosis.
Even if they do, let's say, show an impact on fibrosis, many years behind us, we're gonna already be moving through the outcomes portion of our study at that point, and we will have had, you know, years of head start working with physicians that are focused on the liver. And usually, when you talk to specialists, while they think about the whole person, they usually like to target the organ that they're responsible for. So I think, again, having a, you know, first in disease, liver-directed therapy will be helpful. So, you know, there's lots of different pathways to still having enough of a market for us, but I really believe that we're gonna set a bar, a standard that's gonna be hard for anyone to match. And, you know, never underestimate the importance of being first in any category.
You know, we do have that, I don't want to say luxury, but based on the graveyard before us, and I don't see anything behind us that's so terribly interesting, I think that resmetirom really becomes the foundational therapy in NASH. So, you know, look, I eventually, having other products for NASH and competition, that's a good thing because that will help expand the market. You know, just most recently, having been on Dupixent, not on Dupixent, but working on Dupixent, every time a competitor entered the market, you had greater market growth, and with the best profile, you ended up getting the disproportionate benefit of that. In this case, it's going to take years for peak penetration in NASH to occur. It's true in any disease. It takes just a long time.
I think with our profile, we're in a great position, even with competition, to be the foundational therapy.
In terms of sort of the GLP-1 category, are hepatologists using those tools today to help their patients, and to what extent?
Yeah, so we've heard reports that some are. One of the things that I've heard in speaking with hepatologists is that in the interest of trying to offer something for patients, since there isn't anything today, they will have a conversation with the patients. If they have an endocrinologist, they'll ask them about it. If they don't have an endocrinologist, they'll talk to the PCP about it, and then if they won't do it, then they would ultimately prescribe if they felt it was necessary and the patient would benefit from it. The reality is, though, it's a very, very small, insignificant portion of patients, NASH patients, that receive a GLP-1 in a weight loss dose today.
Now, well, there's a lot of diabetics with NASH, and in our trials, it was about 14%. And, pardon me, for it was over 50%, patients with diabetes, 14% were on a GLP-1 for a dose for diabetes. And when you look at the treatment effect was the same whether they were on a GLP-1 or not, so that you still had that treatment effect that was from resmetirom. So, you know, there's patients have been, are on GLP-1s for diabetes that were on the trials, et cetera. But, you know, I think that right now there hasn't been this wholesale move towards the hepatologist saying, "You know, we're gonna put everybody on," because there isn't the data, it's not easy to do.
Again, I think that they're really kind of waiting for a liver-directed therapy.
In terms of the data, there are some important data readouts next year, tirzepatide data coming in the beginning of the year, I think, and then later on, more data for semaglutide. How important are those readouts to kind of your plans for resmetirom?
Mm-hmm.
I mean, does anything change based on whether or not we do see a fibrosis benefit or do not see a fibrosis benefit?
Well, look, I mean, we continue to look at kind of everyone who's reading out, just because, you know, we think it's important for us to be... As leaders in NASH, we are aware of everything going on. Now, how would in Q1, if there's a readout, how would that affect things? I don't think it would.
Mm.
I mean, realistically, because, you know, we're months away from approval. We're gonna be launching. Our data is our data. Our data is strong. Our profile is strong. You know, when you, when you ask people, what is it they always want? They want a once-a-day pill. We've got a once-a-day pill, and that's something, a once-a-day effective pill, that's something which has an absolute place at the front of the line. So, you know, while we'll see, but remember, it's only Phase II data that people are gonna be reporting anyway, so they still got a long development program, and you've got to prove that again. So, you know, we're gonna stay focused right where we said: hepatologists, gastroenterologists, NASH with significant fibrosis, F2, F3, and think that is a, a piece of the market that we can win in.
What systems need to be in place to really build this market? You know, you can talk about the different pieces.
Yeah. Yeah, I mean, look, I think right now, the NITs are in their, when I say, infancy, there are NITs available, but I think the community is still working through what's gonna be the kind of best sequencing, and people have their different preference. You know, we hear a lot people saying they're gonna use FIB-4 and FibroScan, and that's good. Others talk about ELF, et cetera. And I think you've got to look at the evolution of this disease or this market in time. I think where we are today is gonna be different in three years, in five years. I think that there's gonna be just kind of better understanding of how to sequence testing. There may be even new tests that, as we move to this three- to five-year period, it's just gonna be just much better wired.
I think that's just one of the things that has to take place over time. It's like any new area, you know, until there's a product-
Right
... things don't get as finalized because there's no solution. Once there's a solution, then you have to start thinking about how do you work through to get to that, solution. So I think you'll see just a lot of evolution in the next, in the next period of time. And, you know, part of what we're gonna be doing is help to shape that. Guidelines are gonna be very important. You know, there's a number of sets of guidelines. AASLD has treatment guidelines, and I think those will evolve to include resmetirom once it's available.
Okay, great. And then at the ADA meeting, there was actually a recommendation for all Type 2 diabetics to be screened-
Mm-hmm
... for NASH, actually. Are you expecting kind of an uptick in diagnoses as a result of these kinds of programs?
Yeah, I think, yeah, it's one of those things, when people look, they will find it, because it's a disease that, you know, a lot of people have, right? And it's quite silent. And, you know, we hear stories all the time of a patient that said they've been to their physician, who says they have, you know, fatty liver, that they should go home, modify their life cycle, and in some cases, they've come back as soon as a year later and they're told, "Well, you need a liver transplant." And, you know, really tragic stories, and these aren't people that have led destructive lifestyles. You know, they've just had the conditions such as diabetes, et cetera, that have led to this outcome.
So I think any time now, there are guidelines and recommendations to be looking for it, yet people will start to diagnose it more. Now, you know, what we're focused on, again, is the patients that exist in the specialists that are gonna be treating the disease. What we don't wanna do is we don't want to have all of a sudden, new diagnosis that overwhelms the practices, so they can't see the patients. You know, like with any specialist, you have to schedule in advance. So we wanna work with the community, help them establish their treatment pathways, have them establish reimbursement, have the patients know how to, you know, go through the journey. And once that's formalized, then more referrals can be handled. But, you know, we don't wanna have the practices overburdened out of the gates.
You know, one thing that always comes up time and time again, and if Becky were here, I would not ask this question because she'd be very upset. But I'm gonna ask it of you because you kinda have a fresh eye on it, and you haven't had the question posed as many times. But a lot of people think that biopsies will in fact be required, and of course, it's a way to kind of limit drug usage, right? If that's what you wanna do. So what do you think about that? Is that something that you think is gonna be the case, and if so, how do you work around it?
Yeah, look, I, I don't think it will be required. I don't think it'll be required in the label. I don't think the FDA wants to tell physicians how to diagnose patients. I think in our conversations that we've had with payers, biopsies have not been the topic of conversation. You know, I think it would be... Well, again, remember, these are vertically integrated payers. They own that patient. There's a cost associated, not only the procedure, but the morbidity associated with a liver biopsy. Right now, it's only about 2% of patients have diagnosis confirmed by a biopsy. You know, there's just a practical matter, and, you know, you just can't, you know, practically be biopsying all these people. So I don't think that it's going to be a requirement.
I think, you know, if you look at AASLD, when we started to show kind of the correlation between biopsy and NITs, I think that the evidence is showing very clearly that NITs can in many ways be more effective than a biopsy. Biopsies are not a sure thing, right? The liver, if you're taking such a small section of liver, that it is not necessarily representative of the whole liver. So, you know, we think that and as I say, the NITs, as they get better and better, and people know how to use them, that that is really gonna be the way that you're going to diagnose and kind of watch patients over time.
We're talking about payers. Tell us about the payer profile of the MASH population, F2, F3.
Yeah. So, you know, the commercial patients are in that 50%-55% range, you know, 35%-40%, Medicare, and then the rest, Medicaid. So, you know, we feel we have some pretty good numbers, but as we get closer and closer and see who the patients are that come forward, we'll be able to, we'll be able to hone in on that.
Are you thinking about the IRA and kind of having to negotiate on price, or is that like a good problem to have?
Yeah, look, I think that's in the future. I think right now it's more about how do we establish kind of this foundation for the product? And then we're no different than anyone else. I mean, with the exception of, I think, we have a great asset.
Got it. As biotech, you know, kind of aficionados here in the room, when drugs launch, when we get to this point, we're sort of following every early metric.
Mm.
I know, Bill, you have a really long-term view of building this to be a, you know, a very significant market. What are some early signs? Are there any early signs of success that suggest to you like, we're on the track here to be kind of this market? Like, what are some early signals? Are there any early signals that you'd point investors to?
Yeah. So look, I think that, sales is a real lagging indicator, right? Because, what we have to do is we have to, kind of build the market, which has never been built before, and that takes a lot of work. I mean, you know, just, just think about it from a, from a, a number of dimensions. First of all, from a physician practice dimension, they're not used to being able to have somebody walk out of their office with a prescription, or when they have that patient there, explain to them, "Here's a new product. Here's how, here's how it, it works. Here's what you can expect. Here's- we're gonna have you have a prescription. This is what you can expect after that." So that in itself takes some time.
That's what we're gonna spend time on, making sure it is well wired. Number of practices that have been, if you will, visited and educated. There's a big education component here. We have a medical team right now, which is helping to educate on the disease and so forth. But as we get approval, they're gonna have to be educated, the coordinators, you know, in many practices, you call them biologic coordinators, that know how to work through making sure that they can procure the script for the patient. So we're gonna be spending time on practice dynamics, spending time with the payers to make sure there's a path forward. And, you know, different payers will have different utilization management criteria. We have to work with them to make sure that it's something that's reasonable.
So this all takes, you know, months to put into place, and then patients can start flowing through quickly. But, you know, until you have been to a practice, had the practice prepared and thinking through how they're going to process their patients, et cetera, you know, it's as though it doesn't exist, that opportunity doesn't exist. As we get people educated, we get the reimbursement clear, the patient pathway clear, then you can expect to have the volume coming through, which results in sales. So again, you know, we're building this for having a very significant product. We're building for: How do you rapidly get to peak? It starts with building a great foundation. That doesn't mean that there, you know, there aren't sales out of the gates. There's gonna be, there's gonna be sales, for sure.
You know, we expect that there's gonna be tremendous interest. But, you know, we're gonna build it right and focus on that so that we can really turn on the gas. And I think if you look at, you know, great assets in the past, even, DUPIXENT, for instance, exactly the same type of thing. Build the foundation, and then you start getting into this momentum where, you know, you, start to have the sales coming through. So it's gonna be thoughtfully done. You know, we're, you know, again, I think some, you know, some small companies, based on the assets they have, launch is the destination and a couple quarters afterwards. I'm looking out years, and that each is a step towards building an incredibly valuable company. A great brand, great company.
You talked about this being a specialty product. Are you thinking about using specialty distribution channels then?
Yeah, you know, we haven't, we haven't provided all the details, but yes, it's, it's much more of a, a specialty launch in that sense. It just won't be, you know, go to your, local pharmacy and pick it up.
Okay. And are you going to have, kind of, patient assistance, to help through navigate reimbursement and all that kind of stuff? Is that something you'll have as well?
Yeah, I think it's really-
Okay
... I think it's important to be able to help patients. You know, look, I think that, oftentimes we don't think about affordability, and that's really what we have to be focused on, is how can we make it affordable for patients? So that includes co-pay assistance, and you know, the other tools that are available. We want it to be a pleasant experience for the patient going through the system. We want it for the practices as well. Now, that's, you know, that's hard. You can't change some of the fundamentals of the system. But I think as a company, we have an obligation to really be helping patients through. And, you know, that's something that in other launches, certainly something that I've done, and that'll be one of the certainly the priorities for this launch.
We've been talking mostly about kind of prepping for the U.S. launch and all those-
Mm-hmm
... you know, that whole system. Give us a glimpse into how you're thinking about sort of ex-US, Europe, Japan, Canada-
Yeah
... other areas.
With that emphasis on Canada, you know? Yes, she knows I'm a Canadian.
Don't forget about Canada.
She knows I'm a Canadian.
It just got lumped in there with the U.S.
That's right, that's right. Well, look, so when you don't have a global footprint, you don't have the same ability just to turn everything on all at once. So, you know, our one, two, and three priority are approval in the U.S., four, five, and six are launch in the U.S. Now, the first step in ex-U.S. is a file ex-U.S. So that's something that we will work towards, that's something that we'll report back on. Now, how do we then access that opportunity? You know, I think that's... Also, you've got to look at the time dependency of that.
You know, certainly, as I you know lay out the vision of the company, which is that I wanna be the leading company in NASH. I think that's something that we will be, you know, just by default, by being the only company with a product. But then how do you extend that leadership in the future? You know, being able to participate on a global scale would be something to have that opportunity, that option. So we wanna be extremely thoughtful about the way we would consider commercialization ex-US. So it'll start with the filing, and then we'll really decide on what's gonna be the best way to deploy.
Do you have a preference towards doing it yourself and building organically or partnering?
Well, I mean, and I don't think the two are mutually exclusive. You know, I think you can, you can look, and that's why I wanna keep kind of options open and think through what's gonna be the best thing for us today, and what's the best thing, you know, 1, 3, and 5 years from now.
Okay. You talked about wanting to build. That means we have four minutes left.
Yeah. Sure.
You talked about wanting to build a great company, and you talked about maybe wanting to bring in some other assets. How are you thinking about that? Would these be things within NASH, things within metabolic, something late-stage, something early-stage, you know, or any great asset out there? How are you thinking about it?
Well, look, I think a few things. You know, let me just tell you how I think about it philosophically, is I would rather build a company around a great asset, and that's what I think we have the opportunity to do. And that can be either with other products that you bring in, other capabilities that you can bring in, from, you know, discovery research all the way through. I mean, those are options that you have when you have a great product to build around. For us, you know, resmetirom is just, I think, really a fantastic product. Is it the final solution for NASH? You know, probably not. And I think that the years of experience we have in development of resmetirom puts us in a position to better evaluate the landscape.
So, you know, we're in no rush, but we wanna look always to see, you know, what's coming behind us, what's new, and if there's anything that we think makes sense. You know, I'm a, I'm a, I'm a big believer in- or what I've seen, and it's made me a big believer: when you are in a leadership position in a space, you wanna put yourself in the spot where other companies that are working in the area come to you and say, "We'd like your advice, at least," or, "We'd like to work with you in some way." And, you know, that's something that as, as we get resmetirom launched, we expect that we're gonna have the opportunity to look at things. And we wanna be thoughtful, we wanna make sure that anything that we would do in the future has to match the plan.
Now, you know, I think because NASH is such a significant opportunity and there's, you know, no one there yet, that that would be a priority to extend leadership in NASH. However, if there is a great asset, I will go back to, if there's a great asset in another area, certainly that's something that we'd look at. But again, you know, right now, first three priority is approval, next three, launch ex-US... and how do we build the-
Yeah
future Canada? Well, Canada's ex-US. You know, at least not everyone thinks that way about it, but it actually is, yeah.
Have you done any work on a brand name, and can you please name it something that we can pronounce? That would be really great.
Yeah, no, I mean, I'm a big believer in that. I think it's nice to have names that you understand. No, no update on the brand name. When we have the brand name, we will communicate it.
Will that be a reveal kind of at launch with price and all that kind of stuff?
Yeah. In proximity to launch.
Okay.
Right? In proximity to launch.
Okay.
Yeah. So there's a lot to look forward to. You know, we have-
Give us a glimpse. What, what are the key things now for, like, the next 12 months?
Well, I think... Look, I think everything leading up to launch, as we get closer to launch, we'll provide that next level of detail so that you can make sure that you have kind of the right numbers and so to speak, in the model to work with, and we can give you a better sense of where things are headed. We'll be able to then do a deep dive with the label once we have approval. You'll have price at that point. And then, you know, I think it's just over the rest of 2024, it's just going to be, you know, kind of how we're progressing against all of our plans of making sure that we're educating the community, making sure patients are having a good experience, and also opening up market access.
So there's a lot to come, and I'm really excited about it. You know, somebody asked me the other day: "Are you more excited or less excited than when you joined, you know, nine weeks ago?" And I'd say I'm more excited. I just think the more I look at the product, the data, the opportunity, I really believe this is a unique opportunity within the entire industry.
Well, we're really looking forward to seeing what you do with this product.
Mm.
Thank you so much.
Well, thank you for having me.